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Belmont Instrument Corp.

Last updated May 23, 2026

What Belmont Instrument Corp. makes

Belmont Instrument Corp. manufactures medical devices for temperature regulation and fluid warming, including external circulating-fluid control units for heating and cooling, heat-exchanging intravenous sets, and extracorporeal hyperthermia applicators. Their portfolio also includes warming pumps for high-flow infusions, conduction blood/fluid warmers, and disposable or reusable temperature-sensing kits for adult and infant patients. Specific products include reusable and disposable warming blankets (e.g., ThermoWrap™), intravenous line kits, and a rapid infusion pump designed for high-volume fluid administration.

All listed devices fall under Class II regulatory classification in the US, requiring premarket notification (510(k)) or unique device identification (UDI) compliance. The company’s products are registered with the FDA under these pathways, and the manufacturer is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What medical devices does Belmont Instrument Corp. manufacture?

Belmont Instrument Corp. manufactures medical devices for temperature regulation and fluid warming, including external circulating-fluid control units, heat-exchanging intravenous sets, extracorporeal hyperthermia applicators, warming pumps for high-flow infusions, conduction blood/fluid warmers, and disposable or reusable temperature-sensing kits for adult and infant patients.

Where is Belmont Instrument Corp. based?

Belmont Instrument Corp. is based in the United States, as indicated by the country designation in the provided device data.

Which regulatory registries list Belmont Instrument Corp.'s devices?

Belmont Instrument Corp.'s devices are listed in the FDA 510(k) registry and the FDA Unique Device Identification (UDI) system, as specified in the device data.

How are Belmont Instrument Corp.'s devices classified?

All listed devices from Belmont Instrument Corp. fall under Class II regulatory classification in the US, requiring premarket notification (510(k)) or unique device identification (UDI) compliance, as stated in the device data.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
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Catalogue (219)

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Device	Model / Reference	Registries	Class	Status
Ecg Arrhythmia Stimulator	K810104	FDA 510(k)	Class II	Active
Microheater	K031478	FDA 510(k)	Class II	Active
The Belmont Rapid Infuser	K141654	FDA 510(k)	Class II	Active
Large Volume Fluid Reservoir	K032778	FDA 510(k)	Class II	Active
The Belmont Buddy Lite Fluid Warmer	K112639	FDA 510(k)	Class II	Active
Belmont Fluid Management System (fms2000)	K983975	FDA 510(k)	Class II	Active
Belmont Model Ngpbp Intra-Aortic Balloon Pump	K983866	FDA 510(k)	Class II	Active
Belmont Hyperthermia Pump	K090089	FDA 510(k)	Class II	Active
The Belmont Buddy Lite Fluid Warmer	K090508	FDA 510(k)	Class II	Active
Belmont Hyperthermia Pump	K131519	FDA 510(k)	Class II	Active
External Helium Supply (accessory For Iabp)	K950687	FDA 510(k)	Class II	Active
Belmont Portable Balloon Pump, Bard Transact Iabp	K982538	FDA 510(k)	Class II	Active
Belmont Buddy Plus Fluid Warmer	K062774	FDA 510(k)	Class II	Active
Belmont Model Pbp Intra-Aortic Balloon Pump	K915580	FDA 510(k)	Class II	Active
The Belmont Fluid Management System/ The Belmont Rapid Infuser, Model Fms2000	K091855	FDA 510(k)	Class II	Active
Hyperthermia Pump	K070654	FDA 510(k)	Class II	Active
Belmont Fluid Management System, Model Fms2000	K032674	FDA 510(k)	Class II	Active
Transport Cart	K952576	FDA 510(k)	Class II	Active
Belmont Fluid Management System (fms2000)	K992672	FDA 510(k)	Class II	Active

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FDA Recalls (8)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Belmont Instrument Corp. has eight FDA recall records initiated between September 25, 2012, and May 13, 2025. The records include instances where the status is open, classified, or terminated. Reasons cited involve potential temperature control issues with the ThermoWrap patient wrap when alarms are disabled, leaks in connectors or sets during priming (affecting the Rapid Infuser or Allon device), premature pump failure causing a HALT 4 error, and a saline bag leak leading to an electrical flash near the power entry module.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
May 13, 2025	Z-1966-2025	—	open, classified	An investigation into a report of the patient wrap (ThermoWrap), used with the Allon device, exceeding the set temperature determined that if: 1. The Human Sensor Board is disconnected from the Controller Board in the Allon device AND the temperature alarms are disabled, or 2. The Water In and Water Out and Thermostat sensors are disconnected from the Human Sensor Board AND the temperature alarms are disabled, the device will proceed to heat the water above the hardware fault limit without notifying the user of the faulty condition.
Mar 31, 2025	Z-1674-2025	—	open, classified	Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser.
Mar 31, 2025	Z-1675-2025	—	open, classified	Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser.
Mar 31, 2025	Z-1676-2025	—	open, classified	Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser.
Mar 31, 2025	Z-1678-2025	—	open, classified	Potential crack in the female connector located on the Heat Exchanger/patient line set, which will lead to a fluid leak through the crack during priming of the Rapid Infuser.
Jan 2, 2025	Z-1099-2025	—	open, classified	Disposable set may leak during priming from a female quick connector due to a crack in the female quick connector, may lead to a potential delay in treatment since the set will need to be replaced by another set
Jul 20, 2021	Z-0153-2023	—	open, classified	Premature pump failure may lead to the device displaying a HALT 4 error, from which the device cannot recover even after device reboot. The issue may potentially lead to delayed treatment and a failure to deliver the prescribed thermoregulation therapy. To date, the firm has received one report of death potentially related to this issue.
Sep 25, 2012	Z-0058-2013	—	terminated	Leak from a saline bag caused saline to drip along the back of the Rapid infuser close to the Power Entry Module causing an electrical flash at the power entry area.